Analyte monitoring device and methods of use

• US 6,175,752 B1
• Filed: 04/30/1998
• Issued: 01/16/2001
• Est. Priority Date: 04/30/1998
• Status: Expired due to Term

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Therasense Incorporated (Abbott Laboratories Incorporated)
• Inventors: Heller, Ephraim, Heller, Adam, Say, James, Gal, Yoram, Colman, Fredric C., Aria, Behrad, Plante, Phillip John, Vreeke, Mark S., Friedman, Keith A., Tomasco, Michael F.
• Primary Examiner(s): O'Connor, Cary
• Assistant Examiner(s): ASTORINO, MICHAEL C
• Application Number:
  US09/070,677
• Time in Patent Office: 992 Days
• Field of Search: 600/300-301, 600/346, 600/306-309, 600/345-365, 600/372, 600/385-390, 604/174-180, 128/897-898, 128/903, 128/904, 128/920
• US Class Current: 600/345
• CPC Class Codes: A61B 2560/0252 using ambient temperature
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/002 Monitoring the patient using a local or closed circuit, e.g. in a room or building A61B5/0017 takes precedence
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/14503 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence
• CPC Class Codes: A61B 5/1451 for interstitial fluid
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/72 Signal processing specially adapted for physiological signals or for diagnostic purposes character recognition, recognising digital ink, document-oriented image-based pattern recognition G06V30/00; recognition or understanding of postal images G06V30/424
• CPC Class Codes: A61B 5/7278 Artificial waveform generation or derivation, e.g. synthesising signals from measured signals A61B5/327 takes precedence
• CPC Class Codes: A61B 5/7282 Event detection, e.g. detecting unique waveforms indicative of a medical condition A61B5/4094, A61B5/4818, A61B5/349, A61B5/0823 take precedence
• CPC Class Codes: A61B 5/7405 using sound
• CPC Class Codes: A61B 5/743 Displaying an image simultaneously with additional graphical information, e.g. symbols, charts, function plots
• CPC Class Codes: A61B 5/7445 Display arrangements, e.g. multiple display units
• CPC Class Codes: A61B 5/7455 characterised by tactile indication, e.g. vibration or electrical stimulation
• CPC Class Codes: A61M 5/1723 : using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: C12Q 1/54 : involving glucose or galactose
• CPC Class Codes: G16H 10/40 : for data related to laboratory analysis, e.g. patient specimen analysis
• CPC Class Codes: G16H 20/17 : delivered via infusion or injection
• CPC Class Codes: H01L 23/3107 : the device being completely enclosed
• CPC Class Codes: H01L 23/49548 : Cross section geometry H01L23/49562 takes precedence
• CPC Class Codes: H01L 2924/00 : Indexing scheme for arrangements or methods for connecting or disconnecting semiconductor or solid-state bodies as covered by H01L24/00
• CPC Class Codes: H01L 2924/0002 : Not covered by any one of groups H01L24/00, H01L24/00 and H01L2224/00
• CPC Class Codes: H01L 2924/19041 : being a capacitor
• CPC Class Codes: H01L 2924/3011 : Impedance
• CPC Class Codes: Y10S 128/903 : Radio telemetry
• CPC Class Codes: Y10T 29/49 : Method of mechanical manufacture
• CPC Class Codes: Y10T 29/49124 : On flat or curved insulated base, e.g., printed circuit, etc.

Abstract

An analyte monitor includes a sensor, a sensor control unit, and a display unit. The sensor has, for example, a substrate, a recessed channel formed in the substrate, and conductive material disposed in the recessed channel to form a working electrode. The sensor control unit typically has a housing adapted for placement on skin and is adapted to receive a portion of an electrochemical sensor. The sensor control unit also includes two or more conductive contacts disposed on the housing and configured for coupling to two or more contact pads on the sensor. A transmitter is disposed in the housing and coupled to the plurality of conductive contacts for transmitting data obtained using the sensor. The display unit has a receiver for receiving data transmitted by the transmitter of the sensor control unit and a display coupled to the receiver for displaying an indication of a level of an analyte. The analyte monitor may also be part of a drug delivery system to alter the level of the analyte based on the data obtained using the sensor.

Claims

1. A sensor control unit comprising:

a housing adapted for placement on skin and adapted to receive a portion of an electrochemical sensor extending out of the skin having a plurality of contact pads;

a plurality of conductive contacts disposed on the housing and configured for coupling to the plurality of contact pads on the electrochemical sensor; and

an rf transmitter disposed in the housing and coupled to the plurality of conductive contacts for transmitting data obtained using the electrochemical sensor.

2. The sensor control unit of claim 1, further comprising adhesive for adhering the sensor control unit to skin.

3. The sensor control unit of claim 1, further comprising a mounting unit adapted for coupling with the housing.

4. The sensor control unit of claim 3, wherein the mounting unit is configured for placement between the housing and the skin of the patient.

5. The sensor control unit of claim 3, wherein adhesive is disposed on a surface of the mounting unit for adhering the mounting unit and housing to the skin of the patient.

6. The sensor control unit of claim 3, further comprising a support structure disposed on the mounting unit for aligning the contact pads of the sensor with the conductive contacts of the sensor control unit.

7. The sensor control unit of claim 3, further comprising an opening in the mounting unit configured for guiding insertion of the electrochemical sensor into the patient.

8. The sensor control unit of claim 1, wherein the housing comprises a base and a cover.

9. The sensor control unit of claim 8, wherein the base and cover are configured to form a water resistant seal when coupled.

10. The sensor control unit of claim 1, wherein the housing is water resistant.

11. The sensor control unit of claim 1, wherein the conductive contacts are disposed on an interior surface of the housing.

12. The sensor control unit of claim 11, wherein the housing comprises a port adapted for penetration by the sensor.

13. The sensor control unit of claim 1, wherein the plurality of conductive contacts are disposed on an exterior surface of the housing.

14. The sensor control unit of claim 1, wherein a volume of the housing is about 10 cm³ or less.

15. The sensor control unit of claim 1, wherein a height of the housing is about 0.7 cm or less.

16. The sensor control unit of claim 1, wherein a weight of the housing is about 90 grams or less.

17. The sensor control unit of claim 1, further comprising a battery disposed in the housing.

18. The sensor control unit of claim 17, wherein the battery is sealed within the housing of the sensor control unit.

19. The sensor control unit of claim 17, wherein the battery is removable from the housing.

20. The sensor control unit of claim 1, further comprising an alarm to indicate at least one of hypoglycemia, impending hypoglycemia, hyperglycemia, or impending hyperglycemia.

21. The sensor control unit of claim 20, further comprising a switch for deactivating the alarm.

22. The sensor control unit of claim 20, wherein the alarm produces an audible signal when activated.

23. The sensor control unit of claim 22, wherein a loudness of the alarm increases over time when the alarm is activated.

24. The sensor control unit of claim 20, wherein the alarm produces a vibration when activated.

25. The sensor control unit of claim 20, wherein the alarm is configured to indicate at least two of hypoglycemia, impending hypoglycemia, hyperglycemia, or impending hyperglycemia.

26. The sensor control unit of claim 1, further comprising a receiver disposed in the housing.

27. The sensor control unit of claim 1, further comprising a processing circuit disposed in the housing and coupled to the conductive contacts, the processing circuit is configured for determining a level of an analyte from a signal generated by the sensor.

28. The sensor control unit of claim 27, wherein the processing circuit is configured for determining the level of the analyte in blood from a sensor that is subcutaneously implanted in the patient.

29. The sensor control unit of claim 27, wherein the processing circuit is configured for adjusting the data for temperature using a signal from a temperature probe of the sensor.

30. The sensor control unit of claim 1, wherein the plurality of conductive contacts of the sensor control unit comprise conductive carbon.

31. The sensor control unit of claim 1, further comprising a data storage unit disposed in the housing for keeping data for a period of time.

34. A sensor assembly, comprising:

a sensor comprising at least one working electrode and at least one contact pad coupled to the at least one working electrode; and

the sensor control unit of claim 1.

35. The sensor assembly of claim 34, wherein the plurality of conductive contacts, the plurality of contact pads, or both comprise conductive carbon.

36. The sensor assembly of claim 35, wherein a signal generated by corrosion of the plurality of conductive contacts and the plurality of contact pads when immersed in a 1 mM NaCl solution is 3% or less of a signal generated by the working electrode when exposed to an analyte having a concentration within an expected physiological range.

37. The sensor assembly of claim 35, wherein a signal generated by corrosion of the plurality of conductive contacts and the plurality of contact pads when immersed in a 100 mM NaCl solution is 3% or less of a signal generated by the working electrode when exposed to an analyte having a concentration within an expected physiological range.

38. The sensor assembly of claim 34, further comprising a mounting unit adapted for coupling with the housing.

39. An analyte monitoring system comprising:

a sensor comprising at least one working electrode and at least one contact pad coupled to the at least one working electrode, the sensor being adapted for implantation of a portion of the sensor comprising the working electrode through skin;

the sensor control unit of claim 1; and

a display unit comprising an rf receiver for receiving data from the sensor control unit, and a display coupled to the rf receiver for displaying an indication of the level of an analyte.

40. The analyte monitoring system of claim 39, further comprising a mounting unit adapted for coupling with the housing.

41. The analyte monitoring system of claim 39, wherein the sensor control unit further comprises an rf receiver disposed in the housing and the display unit further comprises an rf transmitter for transmitting to the rf receiver of the sensor control unit.

42. The analyte monitoring system of claim 39, wherein the display unit further comprises an analyzer coupled to the display and the rf receiver for analyzing data from the rf receiver and providing analyzed data to the display.

43. The analyte monitoring system of claim 39, wherein the display unit further comprises a battery coupled to the receiver and display.

44. The analyte monitoring system of claim 39, wherein the display unit further comprises an input device coupled to the display.

45. The analyte monitoring system of claim 39, further comprising a calibrator for providing a calibration value to at least one of the display unit and the sensor control unit.

46. The analyte monitoring system of claim 45, wherein the calibrator is coupled to the receiver of the display unit for providing the calibration value to the sensor control unit.

47. The analyte monitoring system of claim 45, wherein the calibrator provides a calibration value using 1 microliter or less of body fluid.

48. The analyte monitoring system of claim 45, wherein the calibrator comprises a device configured for non-invasive optical assay of analyte.

49. The analyte monitoring system of claim 39, wherein the display unit is portable.

50. The analyte monitoring system of claim 49, wherein the display unit is configured for wearing on a piece of clothing.

51. The analyte monitoring system of claim 49, further comprising a secondary display unit having a power cord for connecting to an electrical outlet, a receiver for receiving data transmitted by the transmitter, and a display coupled to the receiver for displaying the level of the analyte.

52. The analyte monitoring system of claim 51, wherein the display unit and the secondary display unit are configured for exchanging data.

53. The analyte monitoring system of claim 39, wherein the display unit is configured for connection to an electrical outlet.

54. The analyte monitoring system of claim 53, wherein the display unit further comprises at least one of a lamp, a radio, a clock, an interface to a telephone system, an interface to a computer, or a battery backup system.

55. The analyte monitoring system of claim 39, wherein the display unit further comprises an alarm configured for activation if a signal from the transmitter of the sensor control unit is not received with a predetermined time interval.

56. The analyte monitoring system of claim 39, wherein the display unit comprises a pager receiver for receiving pages from an external paging system.

57. The analyte monitoring system of claim 56, wherein the display unit comprises a pager transmitter for sending pages to the external paging system, wherein the pager transmitter is activated when at least one of hypoglycemia, impending hypoglycemia, hyperglycemia, or impending hyperglycemia is indicated.

58. The analyte monitoring system of claim 39, wherein the display unit is configured for coupling to an external download device to transfer data from the display unit.

59. The analyte monitoring system of claim 39, further comprising at least one alarm disposed in the display unit and configured to indicate when a level of an analyte exceeds a threshold level.

60. The analyte monitoring system of claim 59, wherein the alarm is configured to indicate when a level of an analyte is near a threshold level.

61. The analyte monitoring system of claim 60, wherein the alarm is configured to indicate at least one of hypoglycemia, impending hypoglycemia, hyperglycemia, or impending hyperglycemia.

62. The analyte monitoring system of claim 61, wherein the alarm is configured to indicate impending hypoglycemia and is deactivated if an impending hypoglycemia condition does not exist.

63. The analyte monitoring system of claim 61, wherein the alarm is configured to indicate hypoglycemia and is only manually deactivatable.

64. The analyte monitoring system of claim 61, wherein the alarm is configured to indicate hypoglycemia and the alarm, when activated, produces an audible signal that increases in loudness over time.

65. The analyte monitoring system of claim 59, wherein the analyte monitoring system comprises at least two alarms, each alarm producing an audible signal, wherein the signals of the at least two alarms are distinguishable.

66. The analyte monitoring system of claim 39, further comprising a processing circuit in the display unit, the processing circuit being configured to analyze patient-specific data from multiple episodes to predict a patient'"'"'s response to future episodes.

67. The analyte monitoring system of claim 66, wherein the patient-specific data comprises a response to a treatment.

68. The analyte monitoring system of claim 67, wherein the analyte is glucose and the treatment is an administration of insulin.

69. The analyte monitoring system of claim 67, wherein the display unit further comprises an input device for indicating when a treatment is administered.

70. The analyte monitoring system of claim 66, wherein the processing circuit is configured to determine a drug administration protocol in response to the patient-specific data.

71. The analyte monitoring system of claim 66, wherein the patient-specific data is a dosage dependence of a response to a drug.

72. The analyte monitoring system of claim 66, wherein the display unit further comprises an input device for indicating when food has been injested.

73. The analyte monitoring system of claim 72, where the input device is configured for indicating an approximate caloric content of the food.

74. The analyte monitoring system of claim 39, further comprising a temperature measurement device to correct data obtained from the sensor.

75. The analyte monitoring system of claim 74, wherein the temperature measurement device comprises a temperature probe disposed on the substrate.

76. The analyte monitoring system of claim 39, wherein the analyte monitoring system further comprises a drug administration system which dispenses a drug based on the level of the analyte.

77. The analyte monitoring system of claim 76, wherein the drug administration system comprises a receiver for receiving data from at least one of the sensor control unit or display unit to direct dispensing of the drug.

78. The analyte monitoring system of claim 76, wherein the drug administration system comprises at least one of a needle, syringe, pump, catheter, inhaler, or transdermal patch to administer the drug.

79. The analyte monitoring system of claim 76, wherein the drug is insulin.

80. A method for monitoring a level of an analyte using the analyte monitoring system of claim 39, the method comprising:

inserting the sensor into skin of a patient;

attaching the sensor control unit to the skin of the patient;

coupling a plurality of conductive contacts disposed in the sensor control unit to a plurality of contact pads disposed on the sensor;

collecting data, using the sensor control unit, regarding a level of an analyte from signals generated by the sensor;

transmitting the collected data to the display unit using the rf transmitter of the sensor control unit; and

displaying an indication of the level of the analyte on the display of the display unit.

81. The method of claim 80, wherein collecting data comprises generating signals from the sensor and processing the signals into data.

82. The method of claim 80, wherein the data comprises the signals from the sensor.

83. The method of claim 80, further comprising activating an alarm if the data indicates an alarm condition.

84. The method of claim 80, further comprising administering a drug in response to the data.

85. The method of claim 80, further comprising obtaining a calibration value from a calibration device to calibrate the data.

86. The method of claim 85, wherein the calibration device is coupled to the display unit.

87. The method of claim 86, further comprising transmitting the calibration value from a transmitter in the display unit to a receiver in the sensor control unit.

90. A method for monitoring a level of an analyte using the analyte monitoring system of claim 39, the method comprising:

inserting the sensor into skin of a patient;

attaching the sensor control unit to the skin of the patient;

coupling a plurality of conductive contacts disposed in the sensor control unit to a plurality of contact pads disposed on the sensor;

collecting data, using the sensor control unit, regarding a level of an analyte from signals generated by the sensor;

transmitting the collected data to the display unit using the rf transmitter of the sensor control unit;

displaying an indication of the level of the analyte on the display of the display unit; and

replacing the sensor with a new sensor after a period of use.

91. The analyte monitoring system of claim 74, wherein the analyte monitoring system if configured and arranged to determine a temperature near the sensor using two electrodes of the sensor.

92. The analyte monitoring system of claim 39, wherein the sensor further comprises an enzyme non-leachably disposed on the at least one working electrode.

93. The analyte monitoring system of claim 39, wherein the working electrode comprises a mixture of conductive material and an analyte-responsive enzyme.

94. The analyte monitoring system of claim 39, wherein the sensor further comprises a mass transport limiting membrane disposed over the working electrode, the mass transport limiting member maintaining a rate of permeation of the analyte through the mass transport limiting membrane with a variation of no more than 3% per °

C. at temperatures ranging from 30°

C. to 40°

C.

32. A sensor assembly, comprising:

a sensor having a substrate, at least one recessed channel formed in a surface of the substrate, conductive material disposed in the at least one recessed channel to form at least one working electrode and an individual contact pad for each of the at least one working electrodes; and

a sensor control unit for placement on a skin of an animal, the sensor control unit including

a housing having a port through which the sensor penetrates the housing, and

a plurality of conductive contacts disposed in the housing and configured for coupling with the contact pads of the sensor.

33. A sensor assembly, comprising:

a sensor comprising a flexible substrate with at least one working electrode, at least one counter electrode, and at least one contact pad coupled to each of the working and counter electrodes, the sensor being adapted for implantation of a portion of the sensor comprising the working and counter electrodes through skin; and

a sensor control unit comprising

a housing adapted for placement on skin;

a plurality of conductive contacts disposed on the housing and configured for coupling to the contact pads of the sensor; and

an rf transmitter disposed in the housing and coupled to the plurality of conductive contacts for transmitting data obtained using the sensor.

88. An analyte monitoring system comprising:

(a) a sensor comprising at least one working electrode and at least one contact pad coupled to the at least one working electrode, the sensor being adapted for implantation of a portion of the sensor comprising the working electrode through skin;

(b) a sensor control unit comprising,

(i) a housing adapted for placement on skin and adapted to receive a portion of an electrochemical sensor having a plurality of contact pads;

(ii) a plurality of conductive contacts disposed on the housing and configured for coupling to the plurality of contact pads on the electrochemical sensor; and

(iii) an rf transmitter disposed in the housing and coupled to the plurality of conductive contacts for transmitting data obtained using the electrochemical sensor; and

(c) a display unit comprising a receiver for receiving data from the sensor control unit, and a display coupled to the receiver for displaying an indication of the level of an analyte, wherein the transmitter of the sensor control unit and the receiver of the display unit are capable of transmitting and receiving data when separated by a distance of two meters.

89. A sensor control unit comprising:

a housing adapted for placement on skin and adapted to receive a portion of an independent electrochemical sensor extending out of the skin and having at least one contact pad;

at least one conductive contact configured for coupling to the at least one contact pad on the independent electrochemical sensor; and

an rf transmitter disposed in the housing and coupled to the at least one conductive contact for transmitting data obtained using the independent electrochemical sensor.